Shortening informed consent forms doesn't affect clinical trial participants' understanding of the study, according to researchers from US National Institutes of Health's Clinical Center.
As part of the multinational Strategic Timing of AntiRetroviral Treatment (START) trial, researchers led by NIH's Christine Grady randomly assigned trial sites to use either standard or concise consent forms. The concise forms were some 70 percent shorter and contained 1,821 words. The shorter forms also included bulletpoints and tables and were crafted at a simpler reading level.
Shorter forms, the researchers note, can be more quickly reviewed by ethics committees and may allow site leaders more time to discuss important aspects of the study.
The researchers surveyed 2,429 participants who received the standard consent form and 2,000 participants who received the concise consent form to gauge how well they understood what the trial was about. As they report in PLOS One, they found no difference in comprehension between the two groups.
"A concise consent form may have important practical and other advantages, and the results of this study indicate that the use of one does not compromise understanding, satisfaction, or voluntariness in the informed consent process," Grady and her colleagues wrote in their paper.